FDA Inspection 1032526 — Viva Pharmaceutical Inc
The FDA completed an inspection of Viva Pharmaceutical Inc on December 1, 2017 in Richmond. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 1, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Richmond (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1419 | 21 CFR 211.42(c)(8) | Released Drug Products Area |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4336 | 21 CFR 211.150 | Written distribution procedure |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |